Corcept Therapeutics · 1 day ago
Associate Director, Statistical Programming
Redwood City, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$184K/yr - $243K/yr
10+ years expCorcept Therapeutics is leading the way in the research and development of cortisol modulators. The Associate Director is responsible for planning, executing, and ensuring the quality of SAS programming to support statistical analyses for clinical trials.
BiotechnologyHealthcarePharmaceuticalMedical
No H1B
Responsibilities
Work with data management to review CRO generated case report forms, database specifications, and data transfer specifications
Review Statistical Analysis Plan, develop specifications, write and execute SAS programs for study data analysis and preparation for clinical study report
Develop specifications, build and execute SAS programs for internal data reviews, publications, exploratory, post-hoc and regulatory review
Develop SAS macros and tools for repeated program use for exploratory and post-hoc analyses
Manage on-time and quality delivery of CRO-generated analyses results
Review & provide feedback on CRO generated Statistical Analyses Plans and SDTM and ADaM specifications for domain and analysis dataset development, CDISC compliance and and output displays
Validate data and results of statistical analyses generated by CROs
Manage internal programming resources for study deliverables as applicable
Stay current with regulatory requirements on CDISC and clinical regulatory programming standards
Utilize CDISC implementation guides and industry validation software to check compliance of CDISC data packages (SEND, SDTM, and ADaM, define.xmls and reviewer’s guides)
Evaluate CDISC electronic data packages for completeness, regulatory standards compliance and submission readiness as applicable
Participate in standards governance and developing biometric department operational processes as applicable
Works with line manager and/or Head of Statistical Programming to establish and implement programming standards for validation, repeated use, and TMF archival of statistical programs and datasets
Qualification
Required
In-depth knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESS
In-depth knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidances
In-depth knowledge of Pinnacle 21 and how to address errors, warnings to generate acceptable reviewer's guides (SDRG, ADRG)
Knowledge of clinical trial design, data collection, endpoints, statistical methods and standard data summary displays used in oncology and endocrine therapeutic areas preferred
Ability to operate independently in unstructured situations
Ability to communicate technical information to a non-technical audience
Sc/B.A. in Science, Statistics, Mathematics, Computer Science, Engineering, or related field (MS preferred)
10+ years of experience in clinical trial development (late stage preferred)
FDA/EMEA submission experience a plus
Demonstrated ability for project management of statistical programming projects in clinical development
Experience managing delivery of statistical programming projects by CROs
Ability to navigate uncertainty with creative problem solving and take a hands-on, “roll up your sleeves” approach
Company
Corcept Therapeutics
Corcept Therapeutics discovers and develops drugs that regulate the effects of cortisol.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$119.09MKey Investors
Paperboy Ventures
2012-07-02IPO
2012-04-10Post Ipo Equity· $0.53M
2011-01-21Post Ipo Equity· $39M
Leadership Team
Roberto Vieira
President, Oncology
Yuan Xu
Associate Director, Statistical Programming
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